Directorate General for Enterprise and Industry. European Commission. Framework. Rita L Abbate
|
|
- Justina Hamilton
- 7 years ago
- Views:
Transcription
1 European Commission The EU Market Surveillance Framework European Commission i Directorate General for Unit C1: Regulatory approach for the free circulation of goods Rita L Abbate
2 Content 1.Main elements of the New Legislative Framework 2. The new EU market surveillance framework
3 Main elements of the current Review Market surveillance Notified Bodies Role and significance of CE marking Common definitions & obligations/procedures Strengthen system through review of the main features and addition of missing elements e.g. accreditation ti
4 Complementary legislative tools REGULATION Accreditation Market surveillance - internal - imported products common elements Financing for inter- comparisons Applicable from 1 Jan 2010 DECISION Definitions / obligations Notification (criteria / process / accreditation) Conformity assessment procedures Safeguard mechanisms (& market surveillance) marking Basis for future legislation
5 Why strengthen Market Surveillance? Member State responsibility Stop non-compliance / fraud / counterfeit Check products internally/imported products Take corrective measures safeguard clause However, levels and rigour of Market Surveillance differ widely throughout the EU => Distortion of competition => Dangerous products on the market
6 Market surveillance - now CURRENT SITUATION Obligations for Member States Post-market obligations for producers, distributors & economic operators Sectoral AdCo Groups Networks, Rapid intervention, Safeguards Sectoral Directives & GPS-Directive GPS-Directive Sectoral Directives & GPS-Directive
7 REGULATION - DEFINITION Market surveillance means the activities iti carried out and measures taken by public authorities to ensure that products are in compliance with legal requirements set out in the relevant Community harmonisation legislation or do not endanger health, safety or other issues of public interest protection
8 Scope Market Surveillance Products = Substances, preparations & goods produced through a manufacturing process, except food, feed, human blood and tissues, living gplants and animals Lex Specialis Pharmaceuticals, aviation, drug precursors, medical devices and motor vehicles - examples in recitals Border controls All products covered by Community harmonisation legislation
9 Market Surveillance Exemptions (1) Exemptions via product definition Food and feed, human blood and tissues, living plants and animals Exemptions via lex specialis Pharmaceuticals Drug precursors Civil aviation Motor vehicles Medical devices Authorities can take more specific measures according to GPSD (Consumer products)
10 Market Surveillance Exemptions (2) Border controls Specific provisions relating to the organisation of border controls of specific products prevail
11 Market surveillance Overall framework (1) Strengthening of Market surveillance Scope Organisation / Surveillance measures Communication and Co-ordination Restrictive measures Control of products entering the Community Marking General principles Clarification on use and meaning Clarification of role v voluntary marks
12 Market surveillance - Main elements (1) Common minimum requirements in all Member States Organisational/operational requirements - Infrastructures, resources and powers - Oblige checks, take samples - Checks at external borders - Inform users of risks - Ensure follow up of complaints and accidents
13 Market surveillance - Main elements (2) Co-operation mechanism - National level - Community level Improvement of safeguard clause mechanism & information procedure (in Decision!)
14 Timeframe / Process Proposal was adopted by the Commission on 14 February Presidencies DE/PT/SI COREPER adoption 13 February 2008 EP Plenary 21 February 2008 Entry into force 1 January 2010
15 What next? In-depth analysis on the marking issues - preparation of a Communication Initiatives for Market Surveillance Implementation measures EA Review of sectoral directives to bring into line with Decision
16 When? Review of sectoral directives Stable document: discussions start 2008 How? o By groups of directives o By modifying all at the same time o By issue To be decided with sectoral colleagues..
17 Web site addresses New Approach review: New Internal Market Package for Goods: index_en.htm
18 Thank you for your attention
Market Surveillance and revision of GPS Directive
DIRECTORATE GENERAL FOR INTERNAL POLICIES POLICY DEPARTMENT A: ECONOMIC AND SCIENTIFIC POLICIES INTERNAL POLICIES Market Surveillance and revision of GPS Directive Abstract The study examines the relationship
More informationE-COMMERCE AND PRODUCT SAFETY- KEY CHALLENGES
E-COMMERCE AND PRODUCT SAFETY- KEY CHALLENGES Martijn HENDRIKSEN European Commission DG GROW E-COMMERCE IN THE EU E-commerce is growing rapidly at an average annual rate of 22% E-COMMERCE AND PRODUCT SAFETY-
More informationDECISIONS ADOPTED JOINTLY BY THE EUROPEAN PARLIAMENT AND THE COUNCIL
L 218/82 EN Official Journal of the European Union 13.8.2008 DECISIONS ADOPTED JOINTLY BY THE EUROPEAN PARLIAMENT AND THE COUNCIL DECISION No 768/2008/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of
More informationSwedish Market Surveillance Plan
Swedish Market Surveillance Plan 2014 Adopted by the Swedish Market Surveillance Council on 22 November 2013 Contents 1 Introduction... 1 1.1. General information about market surveillance... 1 1.2. This
More informationRECALLS in EUROPE. Past, present, near & further future. Gert Bos BSI Medcon May 2012
RECALLS in EUROPE Past, present, near & further future Gert Bos BSI Medcon May 2012 A C P D Vigilance, vigilant: Continually watchful or on guard; always prepared for possible danger Content 2 Current
More informationPosition Paper on. European Commission proposal for a Regulation on market surveillance of products
The consumer voice in Europe Position Paper on European Commission proposal for a Regulation on market surveillance of products Key issues from a consumer perspective regarding the Product Safety and Market
More informationRESPONSE TO EUROPEAN COMMISSION CONSULTATION ON CROSS BORDER CARE
RESPONSE TO EUROPEAN COMMISSION CONSULTATION ON CROSS BORDER CARE JANUARY 2007 RESPONSE TO EUROPEAN COMMISSION CONSULTATION ON CROSS BORDER CARE: Consultation regarding Community action on health services
More informationDIRECTIVE 2014/32/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
29.3.2014 Official Journal of the European Union L 96/149 DIRECTIVE 2014/32/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 February 2014 on the harmonisation of the laws of the Member States relating
More informationCE Marking. Caveat Emptor Buyer Beware
CE Marking November 2012 ANEC-SC-2012-G-026final The European Association for the Co-ordination of Consumer Representation in Standardisation Av. de Tervueren 32, box 27 B-1040 Brussels, Belgium - phone
More informationFSPFCC04(SQA Unit Code-F88P 04) Ensure you comply with regulations in your financial services environment
Ensure you comply with regulations in your financial services Overview This Standard is about working within the regulatory of the financial services industry. Most organisations within financial services
More informationDRAFT GUIDANCE DOCUMENT ON THE LOW VOLTAGE DIRECTIVE TRANSITION
EUROPEAN COMMISSION Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs Industrial Transformation and Advanced Value Chains Advanced Engineering and Manufacturing Systems DRAFT
More informationConstruction Products Regulation
Construction Products Regulation (305/2011/EU) Engineers Ireland 27 th September 2013 Sarah Neary BE MBA CEng MIEI Senior Adviser Building Standards Environment, Community and Local Government What has
More informationInitial appraisal of a European Commission Impact Assessment
Initial appraisal of a European Commission Impact Assessment European Commission proposal for a Directive on the harmonisation of laws of the Member States to the making available on the market of radio
More informationChanges to Medical Device Regulations
Changes to Medical Device Regulations How these will affect distributors? IMSTA Breakfast Briefing, 24 October 2013 Niall MacAleenan Medical Device Lead, IMB. Slide 1 Content Revision of the medical device
More informationFOOD SAFETY MANAGEMENT SYSTEMS (FSMS): REQUIREMENTS FOR ANY ORGANISATION IN THE FOOD CHAIN (ISO 22000:2005)
FOOD SAFETY MANAGEMENT SYSTEMS (FSMS): REQUIREMENTS FOR ANY ORGANISATION IN THE FOOD CHAIN (ISO 22000:2005) Dr.R.MANAVALAN, M.Pharm., Ph.D. Professor and Research Director, Department of Pharmaceutics,
More informationOverview. Introduction To The Revised GPSD
KELLER AND HECKMAN LLP Serving Business through Law and Science The Revised EU General Product Safety Directive ( GPSD ) and the EU Product Liability Directive: Considerations for Global Consumer Product
More informationMedical Device Directive 2007/47/EC What is New? Are we moving towards Drug Rules?
Medical Device Directive 2007/47/EC What is New? Are we moving towards Drug Rules? CEMO Congress, Paris, February 3rd, 2011 Dr. Martine Dehlinger-Kremer Vice President Global Regulatory Affairs Agenda
More informationCompetentes en Medicamentos
VIII Encuentro de Autoridades Competentes en Medicamentos de los Países Iberoamericanos (EAMI) 12-14 de Mayo 2010 Madrid MARTIN TERBERGER Jefe de la Unidad de Productos Farmacéuticos Nuevas iniciativas
More informationInsurance Europe key messages on the European Commission's proposed General Data Protection Regulation
Position Paper Insurance Europe key messages on the European Commission's proposed General Data Protection Regulation Our reference: SMC-DAT-12-064 Date: 3 September 2012 Related documents: Proposal for
More informationFree Movement of Goods
Free Movement of Goods August 2014 The importance of trade Trade in goods and services represents an important part of the gross domestic product (GDP) of the four members of the European Free Trade Association
More information9627/16 MH/mk 1 DG B 3A
Council of the European Union Brussels, 3 June 2016 9627/16 Interinstitutional File: 2015/0278 (COD) SOC 361 MI 398 ANTIDISCRIM 33 AUDIO 72 CODEC 777 REPORT from: Presidency to: Permanent Representatives
More informationSANITARY AND PHYTOSANITARY MEASURES (SPS)
TEXTUAL PROPOSAL SANITARY AND PHYTOSANITARY MEASURES (SPS) Article 1 Scope and coverage This Chapter applies to all SPS measures that may, directly or indirectly, affect trade between the Parties. This
More informationMedical Devices. AUSTRIA CHSH Cerha Hempel Spiegelfeld Hlawati
Medical Devices AUSTRIA CHSH Cerha Hempel Spiegelfeld Hlawati CONTACT INFORMATION Thomas Zivny Stefan Huber CHSH Cerha Hempel Spiegelfeld Hlawati Parkring 2, A-1010 Wien +43/1/51435-0 Thomas.zivny@chsh.com
More informationEquipment vs. Component
Equipment vs. Component Dipl. Ing. Ursula Aich Regierungspräsidium Darmstadt National focal point for the Market Surveillance in the field of the ATEX-Directive in Germany Chair of ATEX ADCO Free movement
More informationDrink driving European Commission Guidelines
Drink driving European Commission Guidelines Roberto FERRAVANTE Rome, 3 April 2014 Deputy Head of the Road Safety Unit Directorate-General for Mobility and European Commission Road fatalities in EU-28
More informationGUIDELINES ON MEDICAL DEVICES. IVD GUIDANCES : Borderline issues A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single Market : regulatory environment, standardisation and New Approach Pressure equipment, medical devices, metrology MEDDEV. 2.14/1 rev. 1 January
More informationUnited Nations Guidelines for. Consumer Protection
Department of Economic and Social Affairs United Nations Guidelines for Consumer Protection (as expanded in 1999) UNITED NATIONS New York, 2003 United Nations guidelines for consumer protection (as expanded
More informationThe RFID Revolution: Your voice on the Challenges, Opportunities and Threats. Online Public Consultation Preliminary Overview of the Results
The RFID Revolution: Your voice on the Challenges, Opportunities and Threats Online Public Consultation Preliminary Overview of the Results 16 October 2006 Disclaimer: This document is a working document
More informationRegulatory Aspects of Software Defined Radio
Regulatory Aspects of Software Defined Radio Paul Bender Bundesnetzagentur für Elektrizität, Gas, Telekommunikation, Post und Eisenbahnen (BNetzA) ETSI Software Defined Radio (SDR) / Cognitive Radio (CR)
More informationAudit of the control body through the monitoring of compliance with control plan. Measures for the irregularities
Workshop on verification of compliance with product specification for PDO, PGI and TSG Audit of the control body through the monitoring of compliance with control plan Measures for the irregularities Viktorija
More informationMedical Devices. Notified Bodies and the CE certification Process for Medical Devices. European Surgical Robotics Demonstration Day
Medical Devices Notified Bodies and the CE certification Process for Medical Devices European Surgical Robotics Demonstration Day 27 th March 2014, Leuven, Belgium 1 Bart Mersseman Product Manager Medical
More informationProcedure for EFISC, operators and CB s
Feed Safety Incident and Crisis Management Procedure for EFISC, operators and CB s Version 1.0 final Date : March 2014 EFISC Feed Safety Incident and Crisis Management Procedure version 1.0, March 2014
More informationOverview. Health Science Authority. Implementation of ICH guideline in Singapore. Singapore s experience
ICH and Singapore Dr Christina Lim Deputy Group Director, Health Product Regulation Group Senior Advisor, International Collaboration Health Sciences Authority Singapore November 2008 Overview Health Science
More informationInformation Sheet Guidance For IRBs, Clinical Investigators, and Sponsors
Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors FDA Institutional Review Board Inspections Additional copies are available from: Office of Good Clinical Practice Office of Special
More informationCompilation of Community Procedures on Inspections and Exchange of Information
EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE- GENERAL Public Health and Risk Assessment Pharmaceuticals 3 October 2014 EMA/572454/2014 Rev 17 Compliance and Inspection Compilation of Community
More informationUNDERSTANDING THE EC DIRECTIVE 98/79/EC ON IN VITRO DIAGNOSTIC MEDICAL DEVICES
UNDERSTANDING THE EC DIRECTIVE 98/79/EC ON IN VITRO DIAGNOSTIC MEDICAL DEVICES A WHITE PAPER ON THE REQUIREMENTS, REGULATIONS AND OPPORTUNITIES CONTAINED IN EC DIRECTIVE 98/79/EC AND A BRIEF COMPARISON
More informationThis document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
2004R0552 EN 04.12.2009 001.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B REGULATION (EC) No 552/2004 OF THE EUROPEAN PARLIAMENT
More informationWHAT MAKES YOUR OCCUPATIONAL HEALTH AND SAFETY SYSTEMS STANDARD BEST-IN-CLASS?
EMPLOYEE SATISFACTION COMPLIANCE REDUCED RISK REDUCED INCIDENTS FURTHER EXCELLENCE LABOUR CONDITIONS SAFETY HEALTH COMPETITIVE ADVANTAGE WHAT MAKES YOUR OCCUPATIONAL HEALTH AND SAFETY SYSTEMS STANDARD
More informationNEW AND GLOBAL + OLD APPROACH PRODUCT LEGISLATION: A. Standard questionnaire to be filled for each sector individually:
IV. NEW AND GLOBAL + OLD APPROACH PRODUCT LEGISLATION: A. Standard questionnaire to be filled for each sector individually: Sector: Veterinary Medicinal Products 1. Harmonisation of laws including technical
More informationEmerging Device Topics for Regulatory Consideration.. Janine Jamieson May 2015
Emerging Device Topics for Regulatory Consideration. Janine Jamieson May 2015 Disclaimer These are my personal views and not necessarily those of MHRA as an organisation. 2 European regulation of combination
More informationGuidance on the In Vitro Diagnostic Medical Devices Directive 98/79/EC
Guidance on the In Vitro Diagnostic Medical Devices Directive 98/79/EC August 2013 Contents 1 Introduction...3 2 Scope of the directive...3 2.1 What is an in vitro diagnostic medical device?... 3 2.2 Specimen
More informationMemorandum of Understanding between the NSW Ministry of Health and Sydney Water Corporation
Page 1 of 11 Memorandum of Understanding between the NSW Ministry of Health and Sydney Water Corporation This work is copyright. It may be reproduced in whole or in part for study or training purposes
More informationOrdinary Legislative Procedure
Annex 4 LIST OF THE ARTICLES COMING UNDER ORDINARY LEGISLATIVE PROCEDURE The Treaty of Lisbon plans for extension of the so-called "codecision" procedure, which is now called "ordinary legislative procedure",
More informationMedicare Coverage Gap Discount Program (Filling the Donut Hole)
Medicare Coverage Gap Discount Program (Filling the Donut Hole) Summary: Requires drug manufacturers to provide a 50 percent discount to Part D beneficiaries for brand name drugs and biologics purchased
More information12040/1/15 REV 1 LES/ns 1 DG B 3B
Council of the European Union Brussels, 21 September 2015 (OR. en) Interinstitutional File: 2012/0266 (COD) 12040/1/15 REV 1 NOTE From: To: General Secretariat of the Council PHARM 36 SAN 281 MI 567 COMPET
More informationHOW WILL THE EUROPEAN DIRECTIVE ROHS 2 IMPACT THE MEDICAL DEVICE INDUSTRY? February 2012 SPECIAL REPRINT. By James Calder
February 2012 SPECIAL REPRINT HOW WILL THE EUROPEAN DIRECTIVE ROHS 2 IMPACT THE MEDICAL DEVICE INDUSTRY? By James Calder Reproduced with the kind permission of Global Regulatory Press from the Journal
More informationMeasuring Instruments Directive (2004/22/EC) Implementation and Application. Christian Mengersen (PTB, Germany, WG Q.31 Legal Metrology )
REPUBLIC OF CROATIA STATE OFFICE FOR METROLOGY Measuring Instruments Directive (2004/22/EC) Implementation and Application Christian Mengersen (PTB, Germany, WG Q.31 Legal Metrology ) Seminar Legal Metrology
More informationTHE NEW EUROPEAN LEGISLATION ON INVESTIGATION AND PREVENTION OF ACCIDENTS AND INCIDENTS IN CIVIL AVIATION
THE NEW EUROPEAN LEGISLATION ON INVESTIGATION AND PREVENTION OF ACCIDENTS AND INCIDENTS IN CIVIL AVIATION 1 THE NECESSITY FOR A NEW LEGISLATION Modernise Directive 94/56 on accidents investigation; Evolution
More informationEnvironmental protection under TTIP
position // march 2015 Environmental protection under TTIP For our environment Imprint Publisher: Federal Environment Agency Division I 1.4 PO Box 14 06 D-06844 Dessau-Roßlau Tel: +49 340-2103-0 info@umweltbundesamt.de
More informationQUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES
PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 002-3 25 September 2007 RECOMMENDATION ON QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES PIC/S September
More informationCOMMISSION REGULATION (EU)
L 122/22 Official Journal of the European Union 11.5.2011 COMMISSION REGULATION (EU) No 445/2011 of 10 May 2011 on a system of certification of entities in charge of maintenance for freight wagons and
More informationConsultation document on the Review of the Insurance Mediation Directive (IMD) Commission Staff Working Paper
Consultation document on the Review of the Insurance Mediation Directive (IMD) Commission Staff Working Paper This document is a working document of the Internal Market and Services Directorate General
More informationResponse of the German Medical Association
Response of the German Medical Association to the European Commission proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and
More informationGUIDELINES ON THE APPLICATION OF DIRECTIVE 2006/95/EC
GUIDELINES ON THE APPLICATION OF DIRECTIVE 2006/95/EC (ELECTRICAL EQUIPMENT DESIGNED FOR USE WITHIN CERTAIN VOLTAGE LIMITS) AUGUST 2007 (Last Modified: January 2012) Dear User, The provisions of the Low
More informationIV. NEW AND GLOBAL + OLD APPROACH PRODUCT LEGISLATION: A. Standard questionnaire to be filled for each sector individually:
IV. NEW AND GLOBAL + OLD APPROACH PRODUCT LEGISLATION: A. Standard questionnaire to be filled for each sector individually: Sector: Telecommunications 1. Harmonisation of laws including technical regulations
More informationScheme rules for thermal insulation products for building equipment and industrial installations - VDI certification scheme
Scheme rules for thermal insulation products for building equipment and industrial installations - certification scheme April 6, 2011 1. Introduction This document presents the rules of the product certification
More informationPRODUCT CONFORMITY ASSESSMENT
PRODUCT CONFORMITY ASSESSMENT ENHANCING INTERNATIONAL TRADE IN TODAY S GLOBALIZED MARKETS AND FAST GROWING ECONOMY, THE INCREASING VOLUMES OF GOODS TRADED BETWEEN COUNTRIES IS NOT ONLY THE SIGN OF MUTUAL
More informationNEW AND GLOBAL + OLD APPROACH PRODUCT LEGISLATION: A. Standard questionnaire to be filled for each sector individually:
IV. NEW AND GLOBAL + OLD APPROACH PRODUCT LEGISLATION: A. Standard questionnaire to be filled for each sector individually: Sector: Cosmetics 1. Harmonisation of laws including technical regulations 1.1.
More informationNEW AND GLOBAL + OLD APPROACH PRODUCT LEGISLATION: A. Standard questionnaire to be filled for each sector individually:
IV. NEW AND GLOBAL + OLD APPROACH PRODUCT LEGISLATION: A. Standard questionnaire to be filled for each sector individually: Sector: Noise emission in the environment by equipment for use outdoors Directive
More informationComparative analysis between the possible regulatory approaches to GMP compliance TITOLO PRESENTAZIONE
Comparative analysis between the possible regulatory approaches to GMP compliance TITOLO PRESENTAZIONE Dr. Fulvio CARLOTTI, GNOSIS SpA, Corporate QA Director September 26, 2014 Scope of GMP GMP compliance
More informationEU legislation: Product safety (consumer products)
EU legislation: Product safety (consumer products) This document provides a brief outline on the EU product safety legislation, the related responsibilities for exporters of non-food products and the possible
More informationREPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL
EUROPEAN COMMISSION Brussels, 15.7.2015 COM(2015) 345 final REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Review of Directive 2010/30/EU of the European Parliament and of the Council
More informationFuture Regulatory Challenges for In VitroDiagnostics. Trilateral Workshop, Berlin 16&17 June 2010
Future Regulatory Challenges for In VitroDiagnostics Trilateral Workshop, Berlin 16&17 June 2010 Doris-Ann Williams Director General The British In Vitro Diagnostics Association 2 European Regulation of
More informationPUBLIC CONSULTATION ON POSTAL SERVICES
EUROPEAN COMMISSION PUBLIC CONSULTATION ON POSTAL SERVICES PART 2 CONSULTATION ENDS JAN 27 2006 NOV 2005 V1.9 Page 1 of 9 PART 2 CONSULTATION ON POSTAL SERVICES Part 2 asks more detailed questions on a
More informationArticle 29 Working Party Issues Opinion on Cloud Computing
Client Alert Global Regulatory Enforcement If you have questions or would like additional information on the material covered in this Alert, please contact one of the authors: Cynthia O Donoghue Partner,
More informationCOMMISSION IMPLEMENTING DECISION. of XXX. (Text with EEA relevance)
EUROPEAN COMMISSION Brussels, XXX SANCO/12230/2014 CIS (POOL/G2/2014/12230/12230-EN CIS.doc) [ ](2014) XXX draft COMMISSION IMPLEMENTING DECISION of XXX establishing specific transitional measures for
More informationI. What is the DCFTA?
DEEP AND COMPREHENSIVE FREE TRADE AREA EU-MOLDOVA I. What is the DCFTA? Argumentaire The Deep and Comprehensive Free Trade Area (DCFTA) is an arrangement between the EU and the Republic of Moldova that
More informationQuality Management Standard BS EN ISO 9001:2008. www.imsworld.org
Quality Management Standard BS EN ISO 9001:2008 The Origin of Quality Standards Ministry of Defence Marks & Spencer Ford Motor Company All had their own Quality standards, which they expected their suppliers
More informationThe 'Blue Guide' on the implementation of EU product rules. European Commission. Version 1.1 15/07/2015
European Commission The 'Blue Guide' on the implementation of EU product rules 2014 Internal Market, Industry, Entrepreneurship and SMEs Version 1.1 15/07/2015 TABLE OF CONTENTS 1. REGULATING THE FREE
More informationDISCUSSION PAPER ECODESIGN FOR ENERGY RELATED PRODUCTS INTEGRATED INTO OTHER ENERGY RELATED PRODUCTS
DISCUSSION PAPER ECODESIGN FOR ENERGY RELATED PRODUCTS INTEGRATED INTO OTHER ENERGY RELATED PRODUCTS EN EN Table of contents 1. Introduction... 2 2. The Legislative Framework... 3 2.1. Ecodesign Directive...
More informationThe Blue Guide. on the implementation of EU product rules. Enterprise and Industry
The Blue Guide on the implementation of EU product rules 2014 Enterprise and Industry TABLE OF CONTENTS 1. REGULATING THE FREE MOVEMENT OF GOODS...6 1.1. A historical perspective...6 1.1.1. The Old Approach...6
More informationResponse to Insurance Contracts Amendment Bill 2013. December 2012. Submission on behalf of Legal Aid NSW. Consumer Action Law Centre,
Response to Insurance Contracts Amendment Bill 2013 December 2012 Submission on behalf of Legal Aid NSW Consumer Action Law Centre, Insurance Law Service & Consumer Representatives to Treasury Introduction
More informationList of EA Publications. And International. Documents
EA/INF-01 List of EA Publications and International Documents Publication Reference EA-INF/01: 2016 List of EA Publications And International Documents PURPOSE This publication gives the list of EA documents
More informationGUIDANCE NOTE FOR MANUFACTURERS OF CUSTOM-MADE MEDICAL DEVICES
GUIDANCE NOTE FOR MANUFACTURERS OF CUSTOM-MADE MEDICAL DEVICES Foreword This guidance document is informative and advisory and has no legal authority. Individual national enforcement authorities are bound
More informationCouncil of the European Union Brussels, 5 March 2015 (OR. en)
Council of the European Union Brussels, 5 March 2015 (OR. en) Interinstitutional File: 2013/0027 (COD) 6788/15 LIMITE TELECOM 59 DATAPROTECT 23 CYBER 13 MI 139 CSC 55 CODEC 279 NOTE From: Presidency To:
More informationACC AUDIT GUIDELINES - INJURY MANAGEMENT PRACTICES
ACC AUDIT GUIDELINES - INJURY MANAGEMENT PRACTICES Guidelines to understanding the audit standards for the Injury Management Section of the ACC Partnership Programme Please note: There is a separate guideline
More informationInformation and Notices 26 July 2016 INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
Official Journal of the European Union C 272 English edition Information and Notices 26 July 2016 Volume 59 Contents II Information INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGCIES
More informationTitle:: Effective GMP AUDITS for APIs and Formulation Pharma Companies By G.Sundar-Director/Consultant PharmQA Compliance solutions
WELCOME Title:: Effective GMP AUDITS for APIs and Formulation Pharma Companies By G.Sundar-Director/Consultant PharmQA Compliance solutions Contents: Introduction GMP Audit GMP Audit plan GMP Auditing
More informationUpdate: Proposed Medical Device Regulation (MDR) & IVD Regulation (IVDR)
Update: Proposed Medical Device Regulation (MDR) & IVD Regulation (IVDR) Paul Brooks Healthcare Solutions Disclaimer The new regulations are not finalized and subject to change http://medicaldevices.bsigroup.com/en-us/resources/whitepapers-and-articles/
More informationAmerican Association for Laboratory Accreditation
Page 1 of 6 1.0 INTRODUCTION These accreditation requirements are applicable to the special competition animal drug testing laboratory accreditation program. This program is designed to meet the requirements
More informationMarket surveillance of machinery
Joint Position Paper Market surveillance of machinery Executive summary In view of the upcoming Market Surveillance Package (or Safety Package) CECE, CECIMO, CEMA and FEM stress that this is an important
More informationQuality Management System Certification. Understanding Quality Management System (QMS) certification
Quality Management System Certification Understanding Quality Management System (QMS) certification The medical device manufacturing sector is one of the most regulated sectors in which significant quality
More information2016 No. 253 HEALTH AND SAFETY. The Health and Safety and Nuclear (Fees) Regulations 2016
S T A T U T O R Y I N S T R U M E N T S 2016 No. 253 HEALTH AND SAFETY The Health and Safety and Nuclear (Fees) Regulations 2016 Made - - - - 2nd March 2016 Laid before Parliament 7th March 2016 Coming
More informationON FIRE PROTECTION LAW ON FIRE PROTECTION CHAPTER I GENERAL PROVISIONS
Republika e Kosovës Republika Kosovo - Republic of Kosovo Kuvendi - Skupština - Assembly Law No. 04/L-012 ON FIRE PROTECTION Assembly of Republic of Kosovo; Based on Article 65 (1) of the Constitution
More informationLIABILITY FOR DEFECTIVE PRODUCTS
COMMERCIAL COURIER LEGAL DEVELOPMENTS AFFECTING YOUR BUSINESS This column looks at new laws and regulations which will have an impact on your business. LIABILITY FOR DEFECTIVE PRODUCTS by Dr. Frank Chetcuti
More informationFAO/WHO Regional Conference on Food Safety for the Americas and the Caribbean San José, Costa Rica, 6-9 December 2005
Agenda Item 5 Conference Room Document 13 FAO/WHO Regional Conference on Food Safety for the Americas and the Caribbean San José, Costa Rica, 6-9 December 2005 THE FOOD SAFETY REGULATORY SYSTEM IN CANADA
More information4.05e WHS Guidelines for Incident Investigation Procedures Page 1 of 7
Page 1 of 7 1 Purpose It is a legal requirement under the NSW Work Health and Safety Act 2011 and NSW Work Health and Safety Regulation 2011 to identify hazards, assess the risk of those hazards, implement
More informationDisability Discrimination Regulations 1996
Disability Discrimination Regulations 1996 Statutory Rules 1996 No. 27 as amended made under the Disability Discrimination Act 1992 This compilation was prepared on 10 September 2009 taking into account
More information1. Consultation of the Committee (SCFCAH)
GUIDELINES FOR THE DEVELOPMENT OF COMMUNITY GUIDES TO GOOD PRACTICE FOR HYGIENE OR FOR THE APPLICATION OF THE HACCP PRINCIPLES, IN ACCORDANCE WITH ARTICLE 9 OF REGULATION (EC) NO 852/2004 ON THE HYGIENE
More informationRisk Management Plan for Drug Establishments
Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION Risk Management Plan for Drug Establishments Center for Drug Regulation and Research Food and Drug Administration 17 December
More informationHandling impact assessments in Council
QC-76-06-353-EN-C EN COUNCIL OF THE EUROPEAN UNION GENERAL SECRETARIAT Handling impact assessments in Council INDICATIVE GUIDANCE FOR WORKING PARTY CHAIRS ISBN 92-824-3284-X,!7IJ2I2-edcieg! kg611572cee_couv.indd
More informationGuide for Custom-Made Dental Device Manufacturers on Compliance with European Communities (Medical Devices) Regulations, 1994
Guide for Custom-Made Dental Device Manufacturers on Compliance with European Communities (Medical SUR-G0014-1 12 NOVEMBER 2013 This guide does not purport to be an interpretation of law and/or regulations
More informationThe Quality System for Drugs in Germany
The Quality System for Drugs in Germany Prof. Dr. Harald G. Schweim Head of Department for Drug Regulatory Affairs Institute for Pharmacy, University of Bonn Former President of the German Federal Institute
More informationMOS Part 143 Air Traffic Service Training Providers
MOS Part 143 Air Traffic Service Training VERSION 1.0: JUNE 2002 UNCONTROLLED VERSION MOS Part 143 Air Traffic Service Training This is a CASA policy manual. It contains specifications (standards) prescribed
More informationDisability Employment Services Quality Framework Advice V 2.0
Disability Employment Services Quality Framework Advice V 2.0 Disclaimer This document is not a stand-alone document and does not contain the entirety of Disability Employment Services Providers' obligations.
More informationPresidency conclusions on establishing a strategy to combat the manipulation of sport results
COU CIL OF THE EUROPEA U IO EN Presidency conclusions on establishing a strategy to combat the manipulation of sport results 3201st EDUCATIO, YOUTH, CULTURE and SPORT Council meeting Brussels, 26 and 27
More informationPosition of the retail and wholesale sector on the Draft Data Protection Regulation in view of the trilogue 2015
2 September 2015 Position of the retail and wholesale sector on the Draft Data Protection Regulation in view of the trilogue 2015 We support the efforts of EU legislators to create a harmonised data protection
More informationThere is a need for a coordinating role by the Commission supported by the Framework programme, to facilitate and harmonise those developments.
0(752/2*
More informationLegal Profession Amendment (Notification) Regulation 2001
New South Wales Legal Profession Amendment (Notification) Regulation 2001 under the Legal Profession Act 1987 Her Excellency the Governor, with the advice of the Executive Council, and on the recommendation
More informationFebruary 2016. Contact Person: Chiara Giovannini, Senior Manager (Chiara.Giovannini@anec.eu)
POSITION PAPER Response to the European Commission consultation on the proposal for a Directive on accessibility requirements of products and services COM (2015)615/2) February 2016 Contact Person: Chiara
More information